Methods to pair a medical device and at least a remote controller for such medical device

ABSTRACT

A disease management system, methods, and devices are shown and described. In one embodiment, the system includes an infusion pump and a remote controller with the ability to be paired to each other. A method to verify a wireless connection between an infusion pump and a remote controller is shown and described herein. In a further embodiment, a method to verify a wireless connection between an infusion pump and a remote controller is provided. In addition, a method of operating a diabetes management system is provided in which the system includes an infusion pump and at least a remote controller.

BACKGROUND

External infusion devices (e.g., infusion pumps) may be used fordelivering medication to users, such as insulin to diabetics. Portableexternal infusion devices may be attached to a user's belt, for example,or placed in a user's pocket. In external infusion devices deliveringinsulin, for example, the insulin may delivered via a cannula, insertedin subcutaneous tissue of the user.

Some conventional external infusion pumps may communicate remotely withanother controlling device, such as a remote controller that isphysically separated from the external infusion pump, for altering oneor more functional settings of the external infusion pump. One exampleof such device is shown and described in U.S. Pat. No. 6,554,798.Another example is shown and described in US Patent ApplicationPublication Nos. 2005/0022274 and 2005/0215982. Other conventionalinfusion pumps may include a remote controller with a blood glucosemeasurement device. One example of such device is shown and described inUS Patent Application Publication No. 2004/0068230.

SUMMARY OF THE INVENTION

By utilization of various technical features described herein, thecoupling or pairing of a plurality of medical devices to respectiveremote controllers is convenient and potentially safer for the user, andinstances of incorrect device pairing are believed to be reduced. Thesetechnical features are believed to be heretofore unrecognized in theconventional system. Specifically, in one embodiment, a diseasemanagement system is provided that includes a medical device and aremote controller. The medical device includes a display for the deviceand having medical device identification information. The remotecontroller includes a controller display and remote controlleridentification information, in which the medical device display isconfigured to display the controller identification information and thecontroller display is configured to display the medical device'sidentification information when the controller and medical device arelinked to each other.

In a further embodiment, a method to verify a wireless connectionbetween a medical device and a remote controller is provided. The methodcan be achieved by: connecting a remote controller with a medical devicevia a wireless link; providing identification information specific tothe medical device to the remote controller; providing identificationinformation specific to the remote controller on the medical device; andconfirming that the medical device identification is with the remotecontroller and that remote controller identification information is onthe medical device.

In yet a further embodiment, a method of operating a diabetes managementsystem is provided in which the system includes a medical device and atleast a remote controller. The method can be achieved by: exchangingidentification information of the remote controller to the medicaldevice and identification information of the medical device to theremote controller; and permitting control of the medical device by theremote controller upon acceptance of the remote controller'sidentification information in the medical device and acceptance of themedical device's identification information in the remote controller.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate presently preferred embodimentsof the invention, and, together with the general description given aboveand the detailed description given below, serve to explain features ofthe invention, in which:

FIG. 1 illustrates an exemplary operational configuration of oneembodiment of the present invention.

FIG. 2 is a perspective view of a remote controller shown in FIG. 1;

FIG. 3 is a perspective view of the remote controller shown in FIG. 1;

FIG. 4 is a perspective view of a test strip for use with the remotecontroller shown in FIGS. 2 and 3;

FIG. 5 is a simplified schematic view of the remote controller and themedical device exhibiting wireless communication;

FIG. 6 is a flow chart illustrating screens for pairing a remotecontroller and medical device that may be displayed on the remotecontroller, in one exemplary embodiment;

FIG. 7 is a flow chart illustrating screens for pairing a remotecontroller and medical device that may be displayed on the medicaldevice in one exemplary embodiment;

FIG. 8 illustrates notifications that may be displayed on the remotecontroller during the pairing process of a remote controller and medicaldevice in one exemplary embodiment;

FIGS. 9A and 9B illustrate meter home screens that may be displayed onthe remote controller in one exemplary embodiment;

FIG. 10 illustrates a medical device home screen that may be displayedon the remote controller in one exemplary embodiment;

FIG. 11 illustrates a medical device home screen that may be displayedon the medical device in one exemplary embodiment;

FIG. 12 illustrates a medical device setup screen that may be displayedon the medical device in one exemplary embodiment;

FIG. 13 illustrates RF communication setup and test screens that may bedisplayed on the remote controller in one exemplary embodiment;

FIG. 14 illustrates RF communication setup screens that may be displayedon the remote controller in one exemplary embodiment;

FIG. 15 illustrates RF communication setup screens that may be displayedon the medical device in one exemplary embodiment;

FIG. 16A and 16B illustrate bolus calculator setup screens that may bedisplayed on the remote controller in one exemplary embodiment;

FIG. 16B illustrates a series of display screens that can be used toprovide various reports on glucose and insulin analysis;

FIG. 17 illustrates RF communication on/off setup screens that may bedisplayed on the remote controller in one exemplary embodiment;

FIG. 18 illustrates screens for turning RF communication on that may bedisplayed on the remote controller in one exemplary embodiment;

FIG. 19 is a flow chart illustrating screens for unpairing a remotecontroller and medical device that may be displayed on the remotecontroller in one exemplary embodiment;

FIG. 20 illustrates notification screens that may be displayed on theremote controller during unpairing of a remote controller and medicaldevice in one exemplary embodiment;

FIG. 21 is a flow chart illustrating screens for a new pairing of aremote controller and medical device that may be displayed on the remotecontroller in one exemplary embodiment;

FIG. 22 is a flow chart illustrating screens for a new pairing of aremote controller and medical device that may be displayed on themedical device in one exemplary embodiment;

FIG. 23 is a schematic flow chart that illustrates a method ofestablishing an acceptable time window for blood glucose resultsmeasured by a remote controller and relied upon in bolus calculations inone exemplary embodiment;

FIG. 24 is a flow chart illustrating screens for calculating anddelivering a bolus, that may be displayed on the remote controller inone exemplary embodiment;

FIG. 25 illustrates a series of medical device and remote controllerstatus screens that may be displayed on the remote controller in oneexemplary embodiment;

FIG. 26 illustrates a series of logbook and notification screens thatmay be displayed on the remote controller in one exemplary embodiment;

FIG. 27 illustrates a series of medical device history screens that maybe displayed on the remote controller in one exemplary embodiment;

FIG. 28 illustrates a series of warning and notification screens thatmay be displayed on the remote controller, as used in the exemplaryembodiments; and,

FIG. 29 illustrates a series of medical device warning screens that aresimilar in layout, and may be displayed simultaneously on both theremote controller and medical device, as used in the exemplaryembodiments.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The following detailed description should be read with reference to thedrawings, in which like elements in different drawings are identicallynumbered. The drawings, which are not necessarily to scale, depictselected exemplary embodiments and are not intended to limit the scopeof the invention. The detailed description illustrates by way ofexample, not by way of limitation, the principles of the invention. Thisdescription will clearly enable one skilled in the art to make and usethe invention, and describes several embodiments, adaptations,variations, alternatives and uses of the invention, including what ispresently believed to be the best mode of carrying out the invention.

Preferred embodiments described and illustrated herein are directedgenerally to a system having a remote controller, which may wirelesslycommunicate with a medical device that dispenses a fluid or medicationand various methods of operation. We will describe, via the use ofexamples, how the remote controller and the medical device wirelesslycommunicate identification information with each other, how icons areused to notify a user that a wireless link that has been establishedbetween the remote controller and medical device, how similar userinterfaces are used on both the remote controller and medical device,who multiple remote controllers can be paired with a medical device, howtime windows are established for measured blood glucose values, and howdevice identification can be used with command histories.

As used herein, the terms “about” or “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein. In addition, as used herein, the terms“patient”, “host” and “subject” refer to any human or animal subject andare not intended to limit the systems or methods to human use, althoughuse of the subject invention in a human patient represents a preferredembodiment.

Referring to FIG. 1, an operational configuration of a remote controller200 and a medical device 300 is shown in which the device 300 isphysically connected to a user to provide monitoring of physiologicalparameters (e.g., heart or brain activities, body temperature, glucoselevel), active intervention (e.g., brain or cardiac management), orinfusing of medication or bioactive agents. In the exemplaryembodiments, the medical device 300 is configured as an insulin infusionpump 300, which, when placed in a wireless link with a specified remotecontroller 200, can indicate identification information specific to theremote controller (as “Controller 1AB3DE” which is printed or affixed tothe remote controller 200). Conversely, the remote controller 200, whenplaced in the wireless link with the infusion pump 300, can indicateidentification information specific to the infusion pump (as “Pump123456” which is printed or affixed to the pump 300).

Thus, as configured and to be described in additional detail below, adisease management system can be configured for a chronic disease suchas diabetes where the system includes a medical device, which has adisplay for the device and a remote controller. The remote controllerhas a controller display with the controller having controlleridentification information. In this system, the medical device displayis configured to display the controller identification information, andthe controller display is configured to display the medical device'sidentification information when the controller and medical device arelinked to each other via a wireless link. As used herein, a “link” is abidirectional communication connection using radio waves, microwave,ultraviolet, infrared or combinations thereof. In this system, thecontroller display includes a first screen representative of analytemeasurement information and a second screen representative of aninfusion pump operational information. Of note is the use of a generallycommon or identical user indicia and user interface for both the medicaldevice and the remote controller. As used herein, the term “userindicia” indicates the graphical text, symbols, light or sounds and theparticular arrangement of the text, symbols, light or sounds to definevarious functional screens (e.g., menus) to allow for programming andcontrolling of the controller 200 and pump 300 whereas the term “userinterface” indicates the components such as buttons, switches or even avoice response interface in combination with the user indicia to allowfor inputs or commands by the user. With the use of a display on theremote programmer, instructional graphics can be used to walk the userthrough various modes of the system, thereby making the system even moreuser friendly. By virtue of the system, a method is obtained in whichthe infusion pump and the remote controller are paired by exchangingidentification information, which may include a serial number of thedevice; names; icons; avatars, speech identification, sounds, orcombinations thereof. Also, where appropriate, the method allows for thepairing of additional remote controllers while unlinking or decouplingwith any other previously paired remote controller.

FIG. 2 is a perspective view of a remote controller 200 for use in theexemplary embodiments. Remote controller 200 includes a first housing201, a first display 202, a first OK button 204, a first down button206, back button 208, a first up button 210, light emitting diode (LED)212, and strip port connector (SPC) 214. Remote controller 200 isschematically shown in FIG. 5 to further include the followingfunctional components such as a first display (DIS) 202, a firstnavigational buttons (NAV) 216, a first radio frequency module (RF) 218,a blood glucose measurement (BGM) module 220, a first battery (BAT) 222,a wired communication port (COM) 224, a first alarm (AL) 226, a firstmicroprocessor (MP) 228, a memory portion (MEM) 230, and a memory chipport (MCP) 232 as shown in FIG. 5. In one exemplary embodiment, shownhere in FIG. 2, a first housing 201 is ergonomically designed to behandheld and to incorporate the functional circuitry required formeasuring glucose episodically and adapted to allow wirelesscommunication with infusion pump 300.

Referring back to FIG. 2, the remote controller 200 includes a portcover 209. In one exemplary embodiment, port cover 209 is an elastomericmaterial that covers over a wired connection port 224 (not shown) and amemory chip port 232 (not shown). Examples of a wired connection portmay be a universal serial bus (USB) or IEEE RS 232. Examples of memorysuitable for insertion into memory receiving port may be a flash memorysuch as a SIMM card, a SmartCard, Smart Media, or any devices capable ofstoring data.

Referring to FIGS. 2 and 5, first display 202 may be a liquid crystaldisplay (LCD) to show both textual and graphical information to a user.A user interface (UI) may be software driven menu that is shown on firstdisplay 202 that enables the user to operate remote controller 200. Auser can navigate through the UI using first navigation buttons 216which include first up button 210, first down button 206, first OKbutton 204, and back button 208. In one exemplary embodiment, the UIallows a user to operate infusion pump 300, query the status of infusionpump 300, measure glucose episodically, and to display data on firstdisplay 202 from remote controller 200 and/or infusion pump 300 (e.g.glucose concentration versus time).

First microprocessor 228 may control first display 202, firstnavigational buttons 216, first RF module 218, blood glucose measurementmodule 220, wired communication port 224, first alarm 226, and memorychip port 232. First microprocessor 228 further provides the capabilityto perform various algorithms for the management of a medical treatment.Examples of such algorithms may include a predictive algorithm for auser's glucose concentrations (e.g. an algorithm that predicts a user'sglucose concentration in the future) and a bolus calculator. A bolus isa pre-determined amount of a medication that is dispensed over arelatively short time period. In the case of a bolus calculator, firstmicroprocessor 228 may process inputs such as food data (e.g.carbohydrates), which may be entered manually using first navigationbuttons 216, or via wired communication port 224 from a personalcomputer or like device. Additionally, blood glucose data may beprovided to first microprocessor 228 directly from the blood glucosemeasurement module 220. Using the inputted food data and glucosemeasurement data, a bolus of insulin can be determined, and shown onfirst display 202, and transmit the bolus amount wirelessly from remotecontroller 200 to infusion pump 300. This enables infusion pump 300 todose an appropriate amount of insulin to a user while at the same timereducing the amount of user interactions with infusion pump 300.

First RF module 218 on remote controller 200 provides for bi-directionalcommunication to infusion pump 300 and potentially other devices such asa continuous glucose monitor, a personal computer, a personal digitalassistant, a cell phone, or a second infusion pump, which may dispenseglucose. Exemplary frequencies that may be suitable for use with firstRF module 218 are about 433 MHz, about 863 MHz, about 903 MHz, and about2.47 GHz. In one exemplary embodiment, first RF module 218 may include acommercially available component such as a Chipcon CC 1000, an antenna,and a RF impedance matching network. First RF module 218 may sendcommands to infusion pump 300 such as a basal pump rate, duration ofpump, and bolus amounts. In addition, first RF module 218 may receivedata from infusion pump 300 which includes an alarm indicating anocclusion or low insulin in reservoir, battery lifetime status, acontinuous or semi-continuous glucose reading, and amount of remaininginsulin in reservoir

Wired communication port 224 provides the option of transferring data toor from an external device such as a personal computer. Wiredcommunication port 224 may also be used to upgrade the software memoryportion 230 of remote controller 200. Memory portion 230 may be avolatile memory type such as for example flash memory. Memory portion230 may contain the application and system software for operating remotecontroller 200. Wired communication port 224 may then re-write memoryportion 230 such that the entire application and system software isupgraded. This allows potential bugs in the software to be fixed and maybe used to create added functionality in remote controller 200. Inaddition, a flash memory card may be inserted into memory chip port 232for upgrading remote controller 200 without connecting it to a personalcomputer. Alternatively, the flash memory card may also be used foradding language support, or supplying calibration information (e.g., fora CGMS device to be paired with the controller).

Remote controller includes first alarm 226 which may be in a variety offorms to warn a user of various statuses that might need an actionableresponse. For example, first alarm 226 may include an audio alarm(monophonic beeps or polyphonic tones), a vibratory alarm, or a LED 212which may be a multi-colored LED that can illuminate red, yellow, andgreen light. In one exemplary embodiment, an alarm signal my be used towarn a user that there is a low glucose reading, a partially filledglucose test strip, a low reservoir of insulin, an occlusion in infusionpump 300, a low battery status for infusion pump 300, a low batterystatus for remote controller 200, and an improperly filled test strip.For the previously mentioned situations in which a user may need tointervene because of a potentially dangerous situation, the alarm may bea vibration, audio signal, and/or LED 212 switching from green to red orfrom green to yellow.

FIG. 3 is a perspective view of an infusion pump 300 for use in theexemplary embodiments. Infusion pump 300 includes a second housing 301,a backlight button 302, a second up button 304, a cartridge cap 306, abolus button 308, a second down button 310, a battery cap 312, a secondOK button 314, and a second display 316. Infusion pump 300 may besuitable for use in dispensing medication such as insulin for improveddiabetic therapies. Similar to remote controller 200, second housing 301may include RF transparent material and may be painted with RFtransparent paint. Referring to FIGS. 4 and 5, infusion pump 300 mayfurther include second display (DIS) 316, second navigational buttons(NAV) 318, a reservoir (RES) 320, an infrared communication port (IR)321, a second radio frequency module (RF) 322, a second battery (BAT)324, a second alarm (AL) 326, and a second microprocessor (MP) 328. Inone exemplary embodiment, infusion pump 300 and remote controller 200may bi-directionally communicate using a wireless signal 400 via firstRF module 218 and second RF module 322. Reservoir 320 typically containsinsulin that can be dispensed from infusion pump 300 via tubing and aneedle attached to a user. The tubing and needle may be attached tocartridge cap 306.

Referring to FIGS. 3 and 5, in one exemplary embodiment, the antennaportion of first RF module 218 may be located within first housing 201.Similarly, second RF module 322 may be located within second housing301. In such a case, the material used for first housing 201 and secondhousing 301 may be RF transparent (i.e. does not absorb or interferewith RF signals). Further, if first housing 201 or second housing 301require that it be painted, the paint used may be RF transparent aswell.

First RF module 218 and second RF module 322 further include acommunication protocol that enables remote controller 200 to communicatewith only a particular infusion pump 300. Both remote controller 200 andinfusion pump 300 have a unique identification code embedded in theirrespective first RF module 218 and second RF module 322. This isdesirable because under certain conditions, a second user with a secondinfusion pump 300 may be in close proximity to the first user. It wouldbe undesirable for the first user's remote controller 200 to communicatewith the second user's infusion pump 300. In order to avoid such ascenario, a user must initiate a pairing protocol before using infusionpump 300 for the first time. When initiating the pairing protocol,remote controller 200 and infusion pump 300 exchange their uniqueidentification code (e.g. serial number). In all subsequent wirelesscommunications, the correct unique identification code must beestablished before exchanging data.

In one exemplary embodiment, remote controller 200 may have anintegrated blood glucose meter that can measure glucose episodicallyusing disposable test strips. A test strip, which may be suitable foruse in the exemplary embodiments, is the commercially available OneTouchUltra™ test strip from LifeScan™, Inc. in Milpitas, Calif., U.S.A. Atest strip 100 suitable for use in remote controller 200 is shown inFIG. 4

In addition to measuring glucose episodically, remote controller 200 canalso wirelessly communicate with infusion pump 300 to provideinformation on the analyte measurements to the pump 300. Remotecontroller 200 can send commands to infusion pump 300 to dispense afluid or medication for a pre-determined time period, rate, and/orvolume. In one exemplary embodiment, a user may select from a menu ofbasal programs that have been programmed on infusion pump 300. Inanother embodiment, the user may more specifically set a basal rate, abolus dose, and a combination thereof may be programmed as commands toinfusion pump 300 from remote controller 200. Remote controller 200 canreceive data from infusion pump 300 such as the status of the dispensingof medication (e.g. the dispense rate, amount of medication remaining ininfusion pump 300, or the proportion of medication delivered based onthe amount programmed).

FIG. 6 is a flow chart illustrating screens for pairing a remotecontroller and infusion pump that may be displayed on the remotecontroller, as used in the exemplary embodiments. When pairingcontroller 200 and infusion pump 300, the first screen is splash screen500. Splash screen 500 is displayed when 200 is turned on. If controller200 has not been paired to infusion pump 300, or if RF communicationbetween 200 and infusion pump 300 is turned off, the first screendisplayed after splash screen 500 is meter home screen 502. Meter homescreen 502 typically includes last reading 506, average reading 508,time 510, and battery icon 512. Battery icon 512 indicates the charge infirst battery 222. Pressing first OK button 204 while meter home screen502 is displayed accesses main menu screen 516. Meter settings 518 canbe highlighted by pressing first down button 206. Pressing first OKbutton 204 results in meter settings screen 522. RF 524 can behighlighted by pressing first down button 206, then selected by pressingfirst OK button 204. RF setup screen 528 is then displayed, and pairing530 can be highlighted by pressing first down button 206 followed byfirst OK button 204, resulting in the display of pairing screen 534.Pairing screen 534 instructs the user to activate the pairing mode oninfusion pump 300 then to highlight and select start pairing command538. Once this is done, pairing status screen 542 is displayed,indicating pairing status 544. In the process of pairing, units criteria546 is checked. If the blood glucose units of measure are not the samein remote controller 200 and infusion pump 300 the pairing procedure isaborted. If the blood glucose units of measure are the same in remotecontroller 200 and infusion pump 300, pairing result screen 550 is thendisplayed. Paired infusion pump 552 includes the serial number of thepaired infusion pump. After verifying that paired infusion pump 552 iscorrect, accept command 554 is highlighted and selected. Remote infusionpump home screen 558 is then displayed, and can be toggled with meterhome screen 574 by pressing first down button 206 and first up button210. Remote infusion pump home screen 558 includes infusion pump icon560, toggle icon 562, signal strength icon 564, battery icon 566, time568, and delivery status 570. Infusion pump icon 560 indicates thatremote infusion pump home screen 558 is a display screen that isassociated with infusion pump 300. Remote infusion pump home screen 558includes the serial number of the paired infusion pump, or alternativelycan include a familiar name, assigned by the user to identify infusionpump 300, instead of the infusion pump serial number. Toggle icon 562indicates that additional screens can be viewed by pressing first downbutton 206 or first up button 210. Time 568 displays the current time (aremote controller 200 setting). Signal strength icon 564 indicates RFsignal strength between remote controller 200 and infusion pump 300.Battery icon 566 indicates that infusion pump 300 has a full batterycharge. Delivery status 570 is an infusion pump status indicating activebasal dosing and that infusion pump 300 contains 100 units of insulin.Remote infusion pump home screen 558 can be toggled with meter homescreen 574 using first down button 206 and first up button 210. Meterhome screen 574 includes meter icon 576, indicating that meter homescreen 574 is a display screen related to remote controller 200. Meterhome screen 574 includes toggle icon 578, signal strength icon 580, andbattery icon 582. Toggle icon 578 indicates that additional screens canbe viewed by pressing first down button 206 and first up button 210.Signal strength icon 580 indicates RF signal strength between remotecontroller 200 and infusion pump 300. Battery icon 582 indicates thebattery charge in remote controller 200.

FIG. 7 is a flow chart illustrating screens for pairing a remotecontroller and infusion pump that may be displayed on the infusion pump,as used in the exemplary embodiments. When infusion pump 300 is turnedon, local infusion pump home screen 600 is displayed. Local infusionpump home screen 600 includes time 602, battery icon 604, deliverystatus 606, status command 608, and 610. Time 602 is the time set ininfusion pump 300. This time must match the time set in remotecontroller 200, and displayed as time 510 in FIG. 6. Battery icon 604indicates the battery charge in infusion pump 300. Delivery status 606indicates the current delivery status of infusion pump 300, while statuscommand 608 and 610 are sub-menu items related to infusion pump statusand the main menu of infusion pump 300. After highlighting 610 usingsecond up button 304 and second down button 310, second OK button 314 ispressed and main menu screen 612 is displayed. Second down button 310can be used to highlight setup 614, and second OK button 314 is pressedto display setup screen 615. After highlighting and selecting advanced616, remote setup screen 618 is displayed. RF 620 can be switched to onusing second up button 304, second down button 310, and second OK button314. When RF 620 is on, channel 622 is set to AUTO mode. In AUTO modethe channel for RF communication is selected automatically. In remotesetup screen 624, search 626 is toggled to ON, and then remote setupscreen 628 is displayed. Remote setup screen 628 includes search status630. Search status 630 indicates that second RF module 322 is searchingfor compatible RF signal from other devices, such as first RF module218. Once a device is found, remote setup screen 634 is displayed, thechannel over which RF communication occurs is displayed in channel 638,and the user is prompted to confirm paired remote 640 using confirm 642.Once paired remote 640 is confirmed using confirm 642, remote setupscreen 644 is displayed. Remote setup screen 644 includes paired remote646 and next 648. By highlighting next 648 and pressing second OK button314, display 316 displays local infusion pump home screen 650. Sinceinfusion pump 300 is now paired with remote controller 200, remotecontrol icon 652 is displayed. When remote control icon 652 isdisplayed, it indicates that RF is enabled, infusion pump 300 is pairedwith remote controller 200, and that infusion pump 300 is ready toreceive commands from remote controller 200. Remote control icon 652does not indicate RF traffic/activity, signal strength, or health ofcommunications. It simply means that infusion pump 300 is enabled toreceive RF commands from remote controller 200. If remote control icon652 is not displayed on local infusion pump home screen 650 it meansthat RF communication between remote controller 200 and infusion pump300 is disabled, and that infusion pump 300 will not receive commandsfrom remote controller 200.

FIG. 8 illustrates notifications that may be displayed on remotecontroller 200 during the pairing process of remote controller 200 andinfusion pump 300, as used in the exemplary embodiments. Since it isimportant that the units of measure are the same in both boluscalculations and in historical data logs, the pairing feature will failif the units are not identical. In some embodiments, the units can bechanged by the user in both remote controller 200 and infusion pump 300.In other embodiments the units are fixed at the factory and can't bechanged, in which case either remote controller 200 or infusion pump 300are exchanged for models with compatible units of measure. In additionto units of measure, it is also important that remote controller 200 andinfusion pump 300 are set to the same time. This is important inestablishing when blood glucose tests were performed, and in loggingevents such as bolus and basal delivery. Accurate time settings are alsoimportant in monitoring averages at different times of the day.

In the exemplary embodiments, the remote controller 200 and the infusionpump 300 may incorporate a suitable radio frequency communicationsystem, such as, for example, a far-field radio frequency communicationelement (“RF”) for bi-directional communication. The center frequenciescan be any suitable frequencies. In the preferred embodiments, thecenter frequencies are approximately 868 MegaHertz (“MHz”) andapproximately 903 MHz. The system preferably uses the Chipcon™ ProductCC1100 RF Transceiver supporting frequency modulated and FrequencyShifting Keying for data transfer. Manchester encoding can be utilizedto allow for self-clocking as the clock is embedded in the signal.Alternatively, Non-Return-to-Zero or NRZ encoding can also be utilized.As described above, the RF element utilizes a communication protocolthat has a learn mode or “pairing” mode which pairs the two devices(remote controller 200 and infusion pump 300), in which the uniqueidentification code of each communicating device is exchanged. Device“pairing” is a process in which a master (remote controller 200) learnswho its slave is (an infusion pump) and in which the slave (infusionpump) learns who its master (remote controller) is. All devices utilizesuitable information identification, such as, for example, a fixeddevice-type serial number address, sound, or optical identifier.Preferably, the remote controller 200 holds one serial number of theinfusion pump 300 that is paired with the controller 200; the infusionpump 300 stores one single master remote controller's serial number fromwhich it will accept commands; and only one remote controller 200 andone infusion pump 300 may be paired at a time. If a new remotecontroller 200 is to be “paired” to an infusion pump 300, the otherremote controller 200 is “un-paired” or whose communication is ignored.During the pairing process, a communications “channel” is establishedfor the system. The “channel” is preferably a frequency offset from thecenter frequency. The use of channels is believed to provide forcommunication that is more robust. The RF communication can be initiatedby either the infusion pump 300 or the controller 200. In the preferredembodiments, the communication is initiated by the remote controller 200(master). There is a predefined wait-listen period after the remotecontroller 200 transmits to the infusion pump 300, where the remotecontroller 200 listens for a response from the infusion pump 300. Theinfusion pump 300 indicates its state, if it is busy or can communicatewith the remote controller 200. The remote controller 200 will thencommunicate with the infusion pump 300 to ask for the status (alarm,alerts, insulin units delivered, etc.) of the infusion pump, and theinfusion pump will send and receive data upon request to and from theremote controller 200. The RF transmission can utilize a single frame oftransmission. A frame can include a plurality of preamble orsynchronization information, header and data.

In the preferred embodiments, the frame includes preamble andsynchronization information, a frame header and an optional data packetwith cyclic-redundancy-checksum (“CRC”). To conserve battery power,three preamble lengths may be utilized: (1) a long; (2) medium; and (3)short preambles. The long preamble is used for initiating communication,the medium preamble is used for automatic session initiation and a shortpreamble is used once communication is established. The predeterminednumber of preamble bytes to be transmitted will vary within a certainrange instead of a fixed number of preamble bytes. The preamble bytesare sent before the frame to allow the RF receiver to lock and receivethe frame. The variation is caused by the clock jitter of the timer,which may cause the preamble periods to be decreased or increased byabout 25 milliseconds. The short and long preamble periods may beconfigured to account for the shortest possible variations in preambleperiod that could occur because of clock jitter. The buffer time periodmay be configured to have about the same magnitude as the clock jitterin the transmitting device. As a result, the preamble period may beabout greater than or equal to the time periods for the high frequencypower saving mode or the low frequency power saving mode of thereceiving device. Consequently, a transmitting device may reliably androbustly send a sufficiently long preamble that will be properlyreceived by the receiving device even if the transmitting device sendsthe lowest possible preamble length due to clock jitter.

The listening window scheme uses a two-stage sniff interval to optimizecommunication on-times. The frame header includes a command, framenumber, size of the optional data packet and a CRC for the frame header.The communication protocol also incorporates a mechanism to insure thatthe data has been transmitted correctly by validating and verifying thetransmission, this includes a use of a cyclical redundancy check andacknowledgment in the communication. For some RF commands with datapackets, the associated data packet may contain the 1's complement ofanother data field as an added safety check for the receiver. Further,the receiver may respond to the command by repeating data fields of theinitial data packet as a safety check for the originating transmitter.After the initial “pairing” has been completed, the specific address ofthe remote controller 200 and the infusion pump 300 are no longertransmitted as part of the data transmitted, but are contained in theCRC checksum. One example of a communication protocol and methodologythat can be utilized is shown and described in International ApplicationEP06/003650 (Docket No. DDI-5103 PCT), entitled “Method For TransmittingData In A Blood Glucose System And Corresponding Blood Glucose System,”filed on Apr. 20, 2006, which application is hereby incorporated byreference in its entirety into this application herein.

FIGS. 9A and 9B illustrate meter home screens that may be displayed onremote controller 200, as used in the exemplary embodiments. FIG. 9Aillustrates meter home screen 504, a typical display before pairing, andFIG. 9B illustrates meter home screen 574, a typical display afterpairing. Before pairing, meter home screen 504 includes meter icon 576,time 510, battery icon 582, last reading 506, and meter home screen 502.Meter icon 576 indicates that the screen is related to remote controlleractivities. Time 510 is the current time, as set in remote controller200. Battery icon 582 indicates remaining power in remote controller200, and can vary between empty, low, medium, and full. If battery icon582 is empty, no functions are available in remote controller 200, andan alarm screen appears. After pairing, meter home screen 574 includestoggle icon 578, signal strength icon 580, and keys locked icon 584.Toggle icon 578 indicates that the user can switch between meter homescreen 574 and remote infusion pump home screen 558 (described inreference to FIG. 10), by toggling first down button 206 and first upbutton 210. Signal strength icon 580 indicates the status of RFcommunication between remote controller 200 and infusion pump 300, andvaries between RF off icon 585, RF down icon 588, low RF strength icon590, medium RF strength icon 592, and full RF strength icon 594. If noinfusion pump is paired, signal strength icon 580 is not shown. Keyslocked icon 584 indicates that the user interface has been locked, andonly limited functionality is available, preventing inadvertentactivation of controller and infusion pump functions.

FIG. 10 illustrates an infusion pump home screen that may be displayedon remote controller 200, as used in the exemplary embodiments. Remoteinfusion pump home screen 558 is only displayed on remote controller 200if remote controller 200 is paired to infusion pump 300. When remotecontroller 200 is paired to infusion pump 300, the user can togglebetween remote infusion pump home screen 558 and meter home screen 574(illustrated in FIG. 9B) by pressing first down button 206 or first upbutton 210 on remote controller 200. Remote infusion pump home screen558 includes remote infusion pump home screen 586, indicating the serialnumber or friendly name of infusion pump 300 with which remotecontroller 200 is paired. By default, remote infusion pump home screen586 includes the serial number of infusion pump 300 with which remotecontroller 200 is paired. The serial number displayed on remote infusionpump home screen 586 can be checked against the serial number printed onthe back of infusion pump 300. To make remote infusion pump home screen586 more recognizable to the user, the identifying information ininfusion pump 300 can be programmed to display a more common name inremote infusion pump home screen 586 such as “Harold's infusion pump.”The common name displayed on remote infusion pump home screen 586 caninclude a common name only, a common name along with a serial number, oronly the serial number, as in the preferred embodiments. This makes iteasier for a user to confirm correct pairing between remote controller200 and infusion pump 300. In alternative embodiments, other identifierscan be used to help the user in confirmation of correct pairing. Thoseembodiments can included user programmed computer icons, computeravatars, names, sounds, or pictures. Whenever a user displays remoteinfusion pump home screen 558, user programmed computer icons, computeravatars, names, sounds, or pictures can be displayed, indicating to theuser correct pairing between remote controller 200 and infusion pump300. The identifying information in infusion pump 300 can be entereddirectly into infusion pump 300 by way of its keyboard, or it can bedownloaded from a personal computer. Identifying information can also beadded to remote controller 200, and can be displayed whenever remotecontroller 200 is turned on and remote controller related screens aredisplayed, such as meter home screen 574. Remote infusion pump homescreen 558 also includes infusion pump icon 560, toggle icon 562, signalstrength icon 564, battery icon 566, time 568, and delivery status 570.Infusion pump icon 560 is an icon that indicates to the user that theyare viewing an infusion pump related screen. Toggle icon 562 indicatesto the user that they can switch between remote infusion pump homescreen 558 and meter home screen 574 (illustrated in FIG. 9B) bypressing first down button 206 or first up button 210. Signal strengthicon 564 indicates the status of RF communication between remotecontroller 200 and infusion pump 300, as described previously in respectto signal strength icon 580 (in FIG. 9B). Battery icon 566 indicatesremaining power in infusion pump 300, and can vary between empty, low,medium, and full. If battery icon 566 indicates no remaining power ininfusion pump 300, no functions are available in infusion pump 300, andan alarm screen appears. Time 568 is the current time, as entered inremote controller 200 and infusion pump 300. Delivery status 570indicates the delivery status of infusion pump 300, and the remaininginsulin in infusion pump 300.

FIG. 11 illustrates an infusion pump home screen that may be displayedon the infusion pump 300, as used in the exemplary embodiments. Localinfusion pump home screen 600 differs from remote infusion pump homescreen 558 (illustrated in FIG. 10) in that local infusion pump homescreen 600 is displayed on infusion pump 300, while remote infusion pumphome screen 558 is displayed on remote controller 200. In systems thatinclude both remote controller 200 and infusion pump 300, and wherecommands entered on remote controller 200 can control infusion pump 300,it is desirable to have user interface screens on both remote controller200 and infusion pump 300 which allow manipulation and control offeatures on infusion pump 300, such as basal delivery, bolus delivery,infusion pump status, and infusion pump history. In systems that useinfusion pump home screens on both remote controller 200 and infusionpump 300, it is desirable to use user interface elements that are commonon both screens, as can be seen in local infusion pump home screen 600and remote infusion pump home screen 558. Using common user interfaceelements makes it intuitive for a user to control infusion pump 300locally, by using local infusion pump home screen 600, or remotely, byusing remote infusion pump home screen 558. In alternative embodiments,local infusion pump home screen 600 can include identifying information,such as the serial number of infusion pump 300, or a friendly name orrecognizable name, such as “Harold's infusion pump.” Identifyinginformation can help in assuring to a user that they are using thecorrect infusion pump 300. Returning to FIG. 11, local infusion pumphome screen 600 includes time 602, battery icon 604, delivery status606, status command 608, 610, and remote control icon 652. Battery icon604 indicates remaining power in infusion pump 300, and can vary betweenempty, low, medium, and full. If battery icon 604 is empty, no functionsare available on infusion pump 300, and an alarm screen appears. Batteryicon 604 on local infusion pump home screen 600 is similar in functionand appearance to battery icon 566 on remote infusion pump home screen558, maintaining consistency in the user interface of remote controller200 and infusion pump 300. Time 602 displays the current time, asentered in the setup of infusion pump 300. It is similar in appearanceand function to time 568 on remote infusion pump home screen 558.Delivery status 606 indicates the current delivery mode and remaininginsulin in infusion pump 300. Delivery status 606 is similar inappearance and function to delivery status 570 on remote infusion pumphome screen 558. Status command 608 is a submenu, and allows access to aseries of infusion pump status screens. 610 is a submenu that allowsaccess to the infusion pump main menu. Remote control icon 652 is anicon that indicates the infusion pump is under remote control. Whenremote control icon 652 is displayed, RF communication between remotecontroller 200 and infusion pump 300 is enabled, remote controller 200and infusion pump 300 have been paired, and infusion pump 300 is readyto receive remotely entered commands from remote controller 200. In someembodiments, this icon does not indicate RF traffic/activity, signalstrength, or health of communications, as other icons do (such as signalstrength icon 564 in FIG. 10, signal strength icon 580 in FIG. 9B, whichhave been described previously). In other embodiments, remote controlicon 652 can include indication as to RF traffic/activity, signalstrength, or health of communications, or one can also include an iconsuch as signal strength icon 564 or signal strength icon 580 near remotecontrol icon 652. Alternatively, one can also include an icon that lookslike an infusion pump, indicating to the user that local infusion pumphome screen 600 is related to infusion pump functions. This can beparticularly useful in systems that include remote controller 200 andinfusion pump 300, in that a user can get confused as to the function ofvarious screens.

FIG. 12 illustrates an infusion pump setup screen that may be displayedon infusion pump 300, as used in the exemplary embodiments. Remote setupscreen 634 includes RF 620, search 636, channel 638, paired remote 640,confirm 642, next 648, and home 654. RF 620 allows a user to enable ordisable RF communication between infusion pump 300 and remote controller200. When RF 620 is toggled to on, RF communication between infusionpump 300 and remote controller 200 is enabled. When RF 620 is toggled tooff, RF communication between infusion pump 300 and remote controller200 is disabled. If infusion pump 300 is currently paired with remotecontroller 200 when RF 620 is toggled to off, pairing data is preservedso it can be restored when RF is re-enabled. If remote controller 200 iscurrently attempting to pair when RF 620 is toggled to off, the pairingattempt is aborted, and previous pairing data is restored, if available.When RF 620 is toggled to “ON” and infusion pump 300 was previouslypaired to remote controller 200, infusion pump 300 automatically beginspairing to the previously paired remote controller 200. If infusion pump300 was not previously paired to remote controller 200, infusion pump300 prepares itself to be paired for the first time. Search 636 is usedto initiate pairing between infusion pump 300 and remote controller 200.When search 636 is blank, infusion pump 300 is not paired with remotecontroller 200, and it does not contain pairing data. This is the stateof infusion pump 300 when it is turned on for the first time. Unlikeremote controller 200, once infusion pump 300 is paired, there is nomeans to un-pair it. When search 636 is “ON”, pairing between infusionpump 300 and remote controller 200 has begun, and is in process. Whensearch 636 is “DONE”, the pairing search between infusion pump 300 andremote controller 200 has ended, as a result of successful pairing, oras a result of aborted pairing. Channel 638 indicates the method forselecting the channel over which RF communication between infusion pump300 and remote controller 200 will occur. When set to “AUTO”, thesoftware in infusion pump 300 determines the RF channel. Alternatively,the user can select a channel over which RF communication occurs, suchas 1-16. Paired remote 640 displays the pairing status between infusionpump 300 and remote controller 200. When paired remote 640 is blank,infusion pump 300 is not paired with remote controller 200. When pairedremote 640 displays “searching”, infusion pump 300 is attempting to pairwith remote controller 200. When infusion pump 300 has paired with adevice, the device provides confirmation such as, for example, a seriesof tone, a display or other visual indicators. In the preferredembodiments, the paired remote 640 displays the serial number or otheridentifying information (such as a name, computer icon, sounds or seriesof tones/vibrations, etc.) of the device, this allows the user to easilycheck that they have paired with the appropriate device, particularly ifthe identifying information is familiar, such as “Bob's remoteController”. If paired remote 640 displays the serial number of thepaired device, such as remote controller 200, it can be checked againstthe serial number printed on the back of the paired device. Confirm 642is a command that allows the user to confirm RF connection betweeninfusion pump 300 and a paired device, such as remote controller 200. Ifa pairing search is under way, confirm 642 displays a cancel command, incase the user wants to cancel the pairing search. If confirm 642displays a confirm command, and it is not executed by the user, thepairing between infusion pump 300 and remote controller 200 is rejected.This allows a user to reject pairing with the wrong device, such assomeone else's infusion pump.

FIG. 13 illustrates RF communication setup and test screens that may bedisplayed on the remote controller 200, as used in the exemplaryembodiments. RF set up screen 700 is displayed on remote controller 200,and is a remote controller related screen, as indicated by meter icon576. By highlighting and selecting RF test 702, RF test screen 704 isdisplayed. RF test screen 704 includes identification 706, RF channel708, and start 710. Identification 706 identifies the infusion pump 300with which remote controller 200 is paired, and can be in the form of aserial number, a name, or other identifying feature, as mentionedpreviously. RF channel 708 identifies the RF channel over which remotecontroller 200 communicates with infusion pump 300, and was selectedeither automatically by remote controller 200 and infusion pump 300during pairing, or was selected for optimum signal and reception by theuser. Start 710 is a command that initiates the start of an RF test. RFtest screen 712 displays the result of the test, and includes RF channel714, RF signal 716, and RF quality 718. RF channel 714 identifies thechannel over which RF communication occurs between remote controller 200and infusion pump 300, RF signal 716 identifies the strength of the RFsignal, and RF quality 718 identifies the quality of the RF signal. AnRF test is useful in identifying paired infusion pumps infusion pump300, and in troubleshooting the RF communication between remotecontroller 200 and infusion pump 300. When using more than one remotecontroller 200 with a single infusion pump 300, the RF test can also behelpful in displaying pairing specifics to the user.

FIGS. 14 and 15 illustrate RF communication setup screens that may bedisplayed on remote controller 200 and infusion pump 300, as used in theexemplary embodiments. FIG. 14 illustrates RF setup screen 800, which isdisplayed on remote controller 200. When RF channel 802 is highlightedand selected, RF channel selection screens are displayed. Innotification 804, the user is notified that the same RF channel shouldbe used on both remote controller 200 and infusion pump 300, and mustconfirm the notification using confirm 806. Depending on RF channelsettings, either RF channel screen 808 or RF channel screen 812 isdisplayed, with toggle icon 810 indicating that RF channel screen 808can be toggled through several channels, or can be toggled to RF channelscreen 812 for automatic RF channel selection. Screen 808, with manualselection of the appropriate channels is utilized in the preferredembodiments. FIG. 25 illustrates a series of user interface screens thatare displayed on infusion pump 300 and allow a user to eitherautomatically select an RF channel, or to specify an RF channelmanually. In remote setup screen 814, the current RF channel ishighlighted, as illustrated by channel 816. Using second up button 304and/or second down button 310, a different channel number can beselected, as illustrated by channel 820 in remote setup screen 818, orthe channel selection can be set to automatic. Once the desired channelhas been highlighted, second OK button 314 is pressed to programinfusion pump 300 to that channel, and remote setup screen 822 isdisplayed.

FIGS. 16A and 16B illustrate bolus calculator setup screens that may bedisplayed on the remote controller, as used in the exemplaryembodiments. The screens illustrated in FIG. 16A are used when remotecontroller 200 is not paired with infusion pump 300. When remotecontroller 200 is paired with infusion pump 300, calculator settings areautomatically copied from infusion pump 300 to remote controller 200. Asillustrated in FIG. 26B, when pairing remote controller 200 to infusionpump 300, notification 900 is displayed to the user on remote controller200, reminding the user that values stored in remote controller 200 willbe overwritten with those stored in infusion pump 300 when pairingbetween remote controller 200 and infusion pump 300 is confirmed by theuser. When remote controller 200 is used only and only as a stand-alonedevice without being paired with infusion pump 300, bolus calculationscan be performed by remote controller 200 using calculator settingsentered by the screens illustrated in FIG. 16A. In main menu screen 902,bolus 904 is highlighted and selected, leading to customize screen 906.In customize screen 906, calculator setup 908 is highlighted andselected, leading to calculator setup screen 910. In calculator setupscreen 910, various bolus calculator settings can be made, including I:CRatio 912, BG Target 916, BG Delta xxx and IS Factor 918. I:C Ratio 912,BG Target 916, BG Delta xxx and IS Factor 918 are used in calculatingvarious types of bolus delivery, including those that will compensatefor carbohydrate intake and those that will return blood glucose valuesto desired levels. I:C Ratio 912 is used to set an insulin tocarbohydrate ratio, and is used in calculating a bolus that willcompensate for ingestion of carbohydrates from a meal or snack. It isdefined as the approximate number of grams of carbohydrates that can becompensated with one unit of insulin. BG Target 916 allows the user toenter a target blood glucose value. Target blood glucose values are usedwhen maintaining good glycemic control. Although not specificallyillustrated, BG Delta xxx allows the user to enter a value that is addedto and subtracted from the BG Target 916 in order to define anacceptable range of blood glucose values for the user. If the user'scurrent blood glucose reading is within the range then the meter willnot adjust its insulin recommendation to compensate for the bloodglucose reading being above or below BG Target 916.

Among computations made by the remote controller 200 and the infusionpump 300 are, for example, suitable bolus delivery recommendations. In anormal delivery, the entire insulin bolus is delivered all at once. Witha combo bolus delivery, the user can select a percentage of the infusionto deliver at once, termed the “normal” portion, with the remainingpercentage, termed the “extended” portion, delivered over an extendedperiod of time as set by the user. The user can select the initialdelivery amount from 0% to 100% thereby allowing an all extendeddelivery and all normal delivery respectively. A BG combo delivery workslike the combo bolus delivery except that the insulin needed for BGcorrection is added to the normal portion of the delivery.

Each of the devices preferably uses two calculations to provide for therecommended bolus delivery: “ezBG” and “CarbSmart.” The ezBG computationdoes not account for carbohydrates while the CarbSmart calculationincludes carbohydrates. The microprocessor of either the remotecontroller or the infusion pump can perform the ezBG bolus computation.The preferred equation for ezBG Bolus Total is:

ezBG Bolus Total=((BGM−TargetBG)/ISF)−IOB, and ezBG Bolus Total is notnegative.

Where:

-   -   BGM=blood glucose measurement    -   TargetBG=target blood glucose setting at the current time with a        +/− range or user entered target (where BG correction is zero if        the measurement is within tolerance)    -   ISF=insulin sensitivity factor setting at the current time or        user entered factor    -   IOB=calculated Insulin on Board based on the insulin delivered        but not yet absorbed by the body or zero if the IOB feature is        disabled. The curve used to determine the IOB can be an        approximation of the Novolog and Humalog fast-acting insulin        absorption curves

The preferred equations for CarbSmart Bolus Total can be determineddepending on several factors relating to blood glucose measurements:

-   -   In the event that BG>=0 and BG>IOB, CarbSmart Bolus        Total=Carb+(BG−IOB);    -   In the event that BG>=0 and (BG−IOB)<0, CarbSmart Bolus        Total=Carb; and    -   In the event that BG<0, CarbSmart Bolus Total=Carb+(BG−IOB) and        CarbSmart Bolus Total is negative

Where:

-   -   BG=(BGM−TargetBG)/ISF    -   Carb=entered carbohydrates/I:C    -   IOB=calculated Insulin on Board based on the insulin delivered        but not yet absorbed by the body or zero if the IOB feature is        disabled. The curve used to determine the IOB is an        approximation of the Novolog and Humalog fast-acting insulin        absorption curves    -   BGM=blood glucose measurement    -   TargetBG=target blood glucose setting at the current time with a        +/− range or user entered target    -   ISF=insulin sensitivity factor setting at the current time or        user entered factor    -   I:C=insulin to carbohydrate ratio setting at the current time or        user entered ratio.

Users have the option of delivering the recommended CarbSmart BolusTotal as a normal, combo or BG combo delivery. Combo deliveries allowthe user to specify a percentage of the bolus for immediate deliverywith the remainder delivered within the user specified duration. Itshould be noted that the BG can be calculated by the remote controller200 using blood glucose measurement data stored or obtained in theremote controller 200 and transmitted to the device 300.

FIGS. 17 and 18 illustrate screens for turning RF communications on andoff, and may be displayed on remote controller 200, as used in theexemplary embodiments. In FIG. 27, RF setup screen RF setup screen 1000allows the user to select from among several RF setup options. Byhighlighting and selecting RF on/off 1002 a user can toggle RFcommunication on and off. In RF on/off screen 1004, the user is warnedthat communication between remote controller 200 and infusion pump 300will stop when RF is turned off, and is prompted to continue turning RFoff, or to cancel the command. If the RF is already turned off, the userwill be warned that communication between paired devices will bereestablished if RF is turned on, as illustrated in RF on/off screen1008 and RF on 1010 of FIG. 28. Once RF on 1010 has been selected, RFon/off screen 1012 is displayed, indicating that RF communication isbeing reestablished with the previously paired device connection status1016. Once RF has been reestablished, it's indicated to the user by RFon/off screen 1014 and connection status 1018.

FIG. 19 is a flow chart illustrating screens for unpairing a remotecontroller and infusion pump that may be displayed on the remotecontroller, as used in the exemplary embodiments. When remote controller200 is turned on, it displays splash screen 1100, followed by remoteinfusion pump home screen 1102. Remote infusion pump home screen 1102 isdisplayed because remote controller 200 is paired with infusion pump300. Remote infusion pump home screen 1102 includes infusion pump icon560, toggle icon 562, signal strength icon 564, and battery icon 566, asdescribed previously. Infusion pump icon 560 indicates that remoteinfusion pump home screen 1102 is related to infusion pump 300functions, and toggle icon 562 indicates that remote infusion pump homescreen 1102 can be toggled with meter home screen 1104 by pressing firstdown button 206 and first up button 210. Meter home screen 1104 includesmeter icon 576, toggle icon 578, and signal strength icon 580. Metericon 576 indicates that meter home screen 1104 is related to remotecontroller 200 functions, while toggle icon 578 and signal strength icon580 function as described previously. By pressing first OK button 204while remote infusion pump home screen 1102 or meter home screen 1104 isdisplayed, main menu screen 1106 will be displayed. Highlighting andselecting meter settings 1116 causes meter settings screen 1108 to bedisplayed. Highlighting and selecting RF 1118 causes RF setup screen1110 to be displayed, while highlighting and selecting pairing 1120leads to pairing screen 1112. Pairing screen 1112 notifies the user thatremote controller 200 is paired with infusion pump 300 (identified byserial number, or other identifying information as describedpreviously), and allows the user to confirm unpairing by selectingunpairing 1122. After selecting unpairing 1122, meter home screen 1114is displayed, without toggle icon 578 and signal strength icon 580, aswere seen in meter home screen 1104. Toggle icon 578 and signal strengthicon 580 are not displayed in meter home screen 1114 because remotecontroller 200 is no longer paired with infusion pump 300, remoteinfusion pump home screen 1102 is no longer an option for display, andRF is deactivated. When remote controller 200 and infusion pump 300 havebeen unpaired, various warning and notification screens can bedisplayed, such as notification 1124 and notification 1126, illustratedin FIG. 30.

FIG. 21 is a flow chart illustrating screens for a new pairing of remotecontroller 200 and infusion pump 300 that may be displayed on remotecontroller 200, as used in the exemplary embodiments. When remotecontroller 200 is turned on, it displays splash screen 1200, followed byremote infusion pump home screen 1202. Remote infusion pump home screen1202 is displayed because remote controller 200 is paired with infusionpump 300. Remote infusion pump home screen 1202 includes infusion pumpicon 560, toggle icon 562, signal strength icon 564, and battery icon566, as described previously. Infusion pump icon 560 indicates thatremote infusion pump home screen 1202 is related to infusion pump 300functions, and toggle icon 562 indicates that remote infusion pump homescreen 1202 can be toggled with meter home screen 1204 by pressing firstdown button 206 and first up button 210. Meter home screen 1204 includesmeter icon 576, toggle icon 578, and signal strength icon 580. Metericon 576 indicates that meter home screen 1204 is related to remotecontroller 200 functions, while toggle icon 578 and signal strength icon580 function as described previously. By pressing first OK button 204while remote infusion pump home screen 1202 or meter home screen 1204 isdisplayed, main menu screen 1206 will be displayed. Highlighting andselecting meter settings 1216 causes meter settings screen 1208 to bedisplayed. Highlighting and selecting RF 1218 causes RF setup screen1210 to be displayed, while highlighting and selecting pairing 1220leads to pairing screen 1212. Pairing screen 1212 notifies the user thatremote controller 200 is paired with infusion pump 300 (identified byserial number, or other identifying information as describedpreviously), and allows the user to confirm new pairing by selecting newpairing 1222. After selecting new pairing 1222, pairing screen 1214 isdisplayed, instructing the user to activate pairing mode on infusionpump 300, and to select start pairing 1234. Pairing screen 1224 is thendisplayed, indicating that remote controller 200 is searching for a newinfusion pump 300. One parameter that is checked during the pairingsearch is that remote controller 200 and infusion pump 300 have the sameglucose units of measure, as mentioned previously. If remote controller200 and infusion pump 300 do not have the same glucose units of measure,the new pairing process is aborted. Assuming that the same units ofmeasure are found, pairing screen 1228 is then displayed, indicatingthat a new infusion pump 300 has been found, and includingidentification 1236 and any other identifying information, as describedpreviously. After accepting the pairing, remote infusion pump homescreen 1230 is displayed. Remote infusion pump home screen 1230 includesidentifying information for new infusion pump 300, and can be toggledwith meter home screen 1232 using first down button 206 and first upbutton 210.

FIG. 22 is a flow chart illustrating screens for a new pairing of remotecontroller 200 and infusion pump 300 that may be displayed on theinfusion pump, as used in the exemplary embodiments. When infusion pump300 is turned on, local infusion pump home screen 600 is displayed.Local infusion pump home screen 600 includes time 602, battery icon 604,delivery status 606, status command 608, and menu command 610, describedpreviously in reference to FIG. 7. After highlighting menu command 610using second up button 304 and second down button 310, second OK button314 is pressed and main menu screen 612 is displayed. Second up button304 and second down button 310 can be used to highlight setup 614 andsecond OK button 314 is pressed to display setup screen 615. Afterhighlighting and selecting advanced 616, remote setup screen 1300 isdisplayed. Remote setup screen 1300 includes RF 1302, search 1304,channel 1306, and identification 1308. Since infusion pump 300 isalready paired to a remote controller 200, RF 1302 is ON, search 1304indicates DONE, and channel 1306 is set to a channel over which RFcommunication between remote controller 200 and infusion pump 300occurs. Identification 1308 displays identifying information as to thepaired remote controller 200. In remote setup screen 1310, search 1312has been switched to ON, initiating a new pairing search. Remote setupscreen 1314 displays the ongoing search status, where channel 1316 hasautomatically been set to AUTO since a new search is under way, andsearch status 1318 indicates that infusion pump 300 is searching for anew remote controller 200. Once a new remote controller 200 has beenfound, remote setup screen 1320 is displayed. Channel 1322 is set to thenew channel for RF communication that was automatically set by 328, andidentification 1324 displays new identifying information for remotecontroller 200. Confirm 1326 prompts the user to confirm pairing withnew remote controller 200. Once new pairing is confirmed, remote setupscreen 1328 is displayed. Selecting next 1330 completes the new pairingprocess, and returns the display to local infusion pump home screen1332.

In alternative embodiments, multiple remote controllers 200 can bepaired with a single infusion pump 300. This allows a user to havebackup remote controllers 200, or allows them to keep remote controllers200 in multiple locations, such as at home and at the office. Eachremote controller 200 must initially be paired with infusion pump 300 toexchange identifying information. An RF detection algorithm in infusionpump 300 determines if it is possible to transfer remote control fromone remote controller 200 to another. In addition, an acknowledgmentfrom the user is required when switching remote control from one remotecontroller to another. As mentioned previously, each remote controller200 must be initially paired with infusion pump 300. Pairing informationfor each remote controller 200 is stored in non-volatile memory withininfusion pump 300. Pairing information can be stored for several remotecontrollers 200. Pairing information may include an RF address which isunique and assigned by the device manufacturer, an RF type whichidentifies the type of device being paired, a default channel whichspecifies the channel over which communication will occur the next timecommunications are established, flags that include additionalinformation such as hardware/software revision levels and units ofmeasure, and serial numbers that uniquely identify each remotecontroller 200. An algorithm in infusion pump 300 determines when remotecontroller 200 may be changed. While 200 and 300 are paired, and are inRF communication with each other, they routinely communicate. Forinstance, on a regular interval, remote controller 200 requests thestatus of 300 by way of RF communication. If infusion pump 300 does notcommunicate with the currently paired remote controller 200 within afixed time, it will start to search for previously paired, andmemorized, remote controllers 200. For efficiency, the search startswith the most recently paired remote controller 200. The dwell timespent searching for each previously paired controller is based on theminimum system RF sniff time. Once a previously paired remote controller200 is found, the user is prompted to acknowledge transfer of remotecontrol to the previously paired remote controller 200. An advantage ofthis embodiment is that it is easier for the user to switch betweenpreviously paired devices.

FIG. 23 is a schematic flow chart that illustrates a method ofestablishing an acceptable time window for blood glucose resultsmeasured by a remote controller and relied upon in bolus calculations,as used in the exemplary embodiments. The method illustrated in FIG. 23can be used in remote controller 200 or in infusion pump 300. Theprocess begins by in initiating step 1400. Step 1400 can be initiatedimmediately after measuring blood glucose with remote controller 200, orcan be initiated after measuring blood glucose with a separate bloodglucose meter. Step 1400 can be initiated whenever the user would liketo deliver a bolus. Once step 1400 is initiated, memory in remotecontroller 200 or infusion pump 300 is checked for recent blood glucosemeasurements. In a particularly preferred embodiment, recent bloodglucose measurements are those taken within the last 15 minutes. If ablood glucose measurement was taken within the last 15 minutes, it isautomatically entered into the bolus calculator, as illustrated in step1404. Using the recent blood glucose measurement and the calculatorsettings (discussed previously), a recommended bolus is calculated, asillustrated in step 1406. Once a bolus amount has been recommended, thebolus calculation is done, as illustrated by step 1408, and the user hasthe choice of making adjustments to or delivering the recommended bolus.

In the preferred embodiments, BG results are only entered on the pump300 when a bolus calculation is done on the pump 300. That result mustbe manually entered by the user into the pump 300. Such result stored inpump 300 is then transferred to the memory of controller 200 during thenext communication interval.

In situations where a recent blood glucose value is not available, theuser is prompted to retest their blood glucose, as illustrated in step1410. If they choose to retest using remote controller 200, they returnto step 1400 of the process, and the result is automatically transferredto the bolus calculator as in step 1404. If they choose not to retest,or if they retest using a separate blood glucose meter, the user canmanually enter a blood glucose result, as illustrated in step 1414. Assoon as the user manually enters a blood glucose value, the bloodglucose calculator determines a recommended bolus, as in step 1406, andthe user has the choice to adjust or deliver the recommended bolus. Insituations where the blood glucose value is measured with remotecontroller 200 and sent to infusion pump 300 for use in boluscalculations, it is particularly important that the time setting of bothremote controller 200 and infusion pump 300 are the same. If the timesetting of remote controller 200 and infusion pump 300 are not the same,it is impossible to accurately determine the age of a blood glucosereading.

FIG. 24 is a flow chart illustrating screens for calculating anddelivering a bolus, that may be displayed on remote controller 200, asused in the exemplary embodiments. Upon inserting a test strip intoremote controller 200, splash screen 1500 is displayed, followed by testscreen 1502. Test screen 1502 includes meter icon 1528, indicating thatit is a display screen related to remote controller functions. Testscreen 1502 indicates to the user that they should check that the lotcode on their test strips matches the lot code entered in remotecontroller 200. The user is then prompted to apply blood to the teststrip, after which test screen 1506 appears, counting down to a result.Upon completion of the blood glucose test, the blood glucoseconcentration is displayed using result screen 1508. Included in resultscreen 1508 is bolus 1530, which leads to bolus menu screen 1510 whenselected. Bolus menu screen 1510 includes infusion pump icon 1532,identification 1534, and ezBG 1536. Infusion pump icon 1532 indicatesthat bolus menu screen 1510 is related to infusion pump functions,identification 1534 includes identifying information (such as infusionpump serial number or a familiar name), and ezBG 1536 accesses a boluscalculator that allows correction for high blood glucose concentrations.Upon selecting ezBG 1536, ezBG calculator screen 1512 is displayed. Aslong as a blood glucose reading has been made with remote controller 200within the last 15 minutes, actual BG 1538 includes a value for actualblood glucose. If a reading has not been made by remote controller 200within the last 15 minutes, the field contains a default value (obtainedfrom the infusion pump 300), which can be changed by the user. Once anactual blood glucose value has been set (either automatically, or by theuser), ezBG calculator screen 1514 is displayed. After selecting showresult 1546, ezBG total screen 1516 is displayed. ezBG total screen 1516includes recommended bolus 1540, a recommended bolus amount that isbased upon the data entered in ezBG calculator screen 1514. In screenezBG total screen 1518, the user has an option to enter the recommendedbolus amount 1540, or they can alter the user-entered bolus 1542. Onceuser entered bolus 1542 has been entered, ezBG total screen 1520 isdisplayed. By entering go command 1548, bolus delivery begins, asindicated in bolus screen 1522. Initiation of bolus delivery can beaccompanied by visual or audio clues, such as beeps, tunes, or flashinglights. Upon completion of bolus delivery, result screen 1524 isdisplayed, where users can enter comments or return to home screens, asdesired. Although FIG. 24 illustrates the use of a bolus calculator inrespect to blood glucose correction boluses, a similar approach can beused when using bolus calculators to determine a bolus amount tocompensate for carbohydrate intake. In cases where the bolus is used tocompensate for carbohydrate intake, additional parameters are entered bythe user, such as recent carbohydrate intake.

FIGS. 25, 26A, and 27 illustrate a series of screens displayed on remotecontroller 200 that relate to the status of infusion pump 300, thestatus of remote controller 200, the logbook of remote controller 200,and the history of infusion pump 300, as used in the exemplaryembodiments. In FIG. 35, main menu screen 1600 includes submenu itemsystem status 1620. When system status 1620 is selected, system statusscreen 1602 is displayed. Selecting infusion pump status 1622 results indisplay of active basal screen 1604, last bolus screen 1606, dailydelivery screen 1608, combo bolus screen 1610, temporary basal screen1612, and infusion pump codes screen 1614. Active basal screen 1604displays basal delivery by infusion pump 300, last bolus screen 1606displays bolus delivery by infusion pump 300, daily delivery screen 1608displays total delivery by infusion pump 300 for the day, combo bolusscreen 1610 displays the status of combination bolus delivery byinfusion pump 300, temporary basal screen 1612 displays temporary basaldelivery by infusion pump 300, and infusion pump codes screen 1614displays identifying information related to infusion pump 300 such assoftware revision numbers and serial numbers. When system status screen1616 is displayed, meter status 1624 can be selected, resulting indisplay of meter status screen 1618. Meter status screen 1618 includesidentifying information related to remote controller 200, such as theserial number of remote controller 200 and its software revision number.If fast facts/history 1626 is selected while main menu screen 1600 isdisplayed, fast facts/history screen 1628 is displayed, as illustratedin FIG. 26A. Highlighting and selecting logbook 1630 results in thedisplay of logbook entries such as logbook screen 1632 and logbookscreen 1634. In logbook screen 1632, a record related to basal deliveryby infusion pump 300 is displayed. Logbook screen 1632 includes anidentifier (M), indicating that this particular basal delivery byinfusion pump 300 was initiated by a command from remote controller 200.Scroll 1640 indicates that other logbook records can be accessed bypressing first down button 206 and first up button 210. By pressingfirst down button 206 or first up button 210, logbook screen 1634 isdisplayed. Logbook screen 1634 is a record of suspended delivery byinfusion pump 300. Suspend record 1638 includes identifier (P)indicating that the command to suspend delivery by infusion pump 300 wasinitiated on infusion pump 300. Identifiers (M) and (P) illustrate a wayto keep track of whether commands to infusion pump 300 were initiated bythe user by way of remote controller 200 or if commands to infusion pump300 were initiated by the user by way of infusion pump 300. This canhelp in diagnosing problems associated with use of remote controller 200and infusion pump 300, and can not only be kept in user accessible areassuch as a logbook, but can also be written into memory only accessibleby the manufacturer of remote controller 200 and infusion pump 300. Thistype of memory is often referred to as a “black box”, and can be used indiagnosing problems associated with operation of remote controller 200or infusion pump 300. Although FIG. 26A illustrates record retention onremote controller 200, similar approaches can be used to store recordsdirectly on infusion pump 300. In fact, it is often beneficial to keep acopy of all records associated with operation of remote controller 200and infusion pump 300 on both remote controller 200 and infusion pump300. Hence, there can be an all-inclusive “black box” in both remotecontroller 200 and infusion pump 300. If RF communication between remotecontroller 200 and infusion pump 300 are not enabled when the logbook onremote controller 200 is accessed, the user is warned with notification1642. Notification 1642 indicates that delivery data from infusion pump300 may be out of date, and that the user should check logs in infusionpump 300 for up-to-date logbook records. Returning to fast facts/historyscreen 1628, if infusion pump history 1644 is selected, infusion pumphistory screen 1646 is displayed, as illustrated in FIG. 37. Infusionpump history screen 1646 includes bolus 1648, total daily dose 1650,alarm 1652, and graph daily infusion pump totals 1654. When bolus 1648is selected, screens such as bolus screen 1656 and bolus screen 1658 aredisplayed. Bolus screen 1656 and bolus screen 1658 are examples of bolusdelivery records, and may include information regarding commandorigination (M) or (P), time of bolus, type of bolus, amount of bolus,and degree of completion of bolus. When total daily dose 1650 isselected on infusion pump history screen 1646, records such as totaldaily dose screen 1660 are displayed. Total daily dose screen 1660summarizes total daily delivery by infusion pump 300, and can includeinformation regarding the date, the amount of temporary delivery, thenumber of suspended deliveries, the amount of bolus delivery, the amountof basal delivery, and the total delivery for that day. When alarm 1652is selected on infusion pump history screen 1646, records such as alarmscreen 1662 are displayed. Alarm screen 1662 includes alarm records forinfusion pump 300, such as the time and date of the alarm, codes for thealarm, and a description of the alarm. Alarm records can also includeidentifying information to indicate if the alarm is a result of commandsentered by the user using remote controller 200 or infusion pump 300.When graph daily infusion pump totals 1654 is selected when infusionpump history screen 1646 is displayed, screens such as graph 1664 aredisplayed, graphically illustrating daily delivery totals for infusionpump 300.

Referring to FIG. 26B, at least one of display of the remote controller200 or infusion pump 300 can be utilized to display information relatingto blood glucose measurements in a graphical format on a display screen,shown here in screens GA1-GA6. Under the “Fast Facts/History” screen ofFIG. 26A, the Glucose Analysis screen can be selected to provide formenu screen GA1. Under GA1, analytical information are provided such as,for example, under screen GA1, a graph of all glucose measurementresults stored in at least one of the remote controller and pump; underscreen GA2, the information relating to blood glucose measurementsinclude a graph of blood glucose measurement results as indexed by timeof day; under screen GA7, the information include a graph of bloodglucose measurements and insulin doses stored on at least one of theremote controller and infusion pump; under screen GA3, the informationinclude an average of at least one of blood glucose measurements andinsulin doses; under screen GA4 the information relating to bloodglucose measurements comprise an average of at least one of bloodglucose measurements and insulin doses indexed by time of day; underscreen GA5, the information include an average of at least one of bloodglucose measurements and insulin doses indexed by exercise events.

To illustrate the unrecognized advantage of the utilization of thepreferred remote controller, two examples are set forth herein. Underscreen GA7, the user or clinician can select the graphical patterns ofblood glucose measurements and insulin as indexed against time in Callscreen, which becomes graphical screen GGI1. Under GGI1 screen, thedisplay provides two graphs indexed against time. A top graph in theGGI1 screen displays blood glucose measurement over time in units ofmg/dL while a bottom graph displays insulin doses in Units over time.Various trends, patterns, and messages can be determined and provided tothe user or health care provider using at least the blood glucosemeasurements and insulin doses as further described in U.S. patentapplication Ser. No. 11/688,639 filed on Mar. 20, 2007, whichapplication is incorporated herein by reference. Under screen GA3, theaverage of all blood glucose results can be displayed in a columnarformat on screen FF33.

FIGS. 28 and 29 illustrate a series of warnings and notifications thatare displayed on remote controller 200 and infusion pump 300. Thewarnings and notifications apply to operation of remote controller 200and infusion pump 300, and to RF communication between remote controller200 and infusion pump 300. FIG. 28 illustrates warnings andnotifications that are displayed on remote controller 200, while FIG. 29illustrates warnings that are displayed on both remote controller 200and infusion pump 300. In respect to FIG. 28, warning screen 1700 isdisplayed when remote controller 200 was able to locate infusion pump300, but the pairing procedure was canceled before it was completed.Warning screen 1702 is displayed if remote controller 200 is unable tolocate infusion pump 300 during the pairing procedure. Remote controller200 and infusion pump 300 may not be within RF range (about ˜10 feet orabout 3.0 meters), or pairing mode may not be activated on infusion pump300. Warning screen 1704 is displayed when a bolus was canceled becauseremote controller 200 and infusion pump 300 are unable to communicate(RF is down or deactivated, remote controller 200 and infusion pump 300are not paired, etc.). Notification screen 1706 is displayed if the lastblood glucose reading was taken more than 15 minutes ago and is notcurrent enough for use in the bolus calculator. Notification screen 1708is displayed if communication between remote controller 200 and infusionpump 300 is suspended because infusion pump 300 is in the middle of aprocedure. Notification screen 1710 is displayed if remote controller200 and infusion pump 300 are no longer paired, and are therefore notable to communicate or share data. Notification screen 1712 is displayedif remote controller 200 and infusion pump 300 are unable tocommunicate. Possible causes are that remote controller 200 and infusionpump 300 are not within RF range or there is RF interference.Notification screen 1714 is displayed when remote controller 200 andinfusion pump 300 are unable to communicate. A possible cause is that RFcommunication has been deactivated. Notification screen 1716 isdisplayed when delivery data on remote controller 200 may not be currentbecause remote controller 200 and infusion pump 300 are unable tocommunicate. Delivery data from infusion pump 300 cannot be viewed onremote controller 200 when remote controller 200 and infusion pump 300are unable to communicate. Notification screen 1718 is displayed when abolus calculator has been accessed, but remote controller 200 andinfusion pump 300 are unable to communicate. The bolus calculator willuse values that were last set and saved on infusion pump 300.Notification screen 1720 is displayed when remote controller 200 andinfusion pump 300 are paired, and bolus calculator values on remotecontroller 200 are replaced by those that were last saved on infusionpump 300. Notification screen 1722 is displayed when a user has chosento unpair remote controller 200 and infusion pump 300. Notificationscreen 1722 warns the user that current calculator settings may not beappropriate for a bolus delivered by devices other than infusion pump300, such as a pen or syringe. Notification screen 1724 is displayedwhen an attempt has been made to initiate an infusion pump function fromremote controller 200 when remote controller 200 and infusion pump 300are not currently paired. Notification screen 1726 is displayed when theglucose unit of measure on remote controller 200 and infusion pump 300do not match. They must match for the pairing procedure to besuccessful. Notification screen 1728 is displayed when the RF Channel onremote controller 200 and infusion pump 300 do not match.

In FIG. 29, various infusion pump warnings are illustrated. The firstcolumn of

FIG. 29 illustrates infusion pump warnings as they are displayed onremote controller 200. The second column of FIG. 29 illustrates the samewarnings as they are displayed on infusion pump 300. Efforts are made tomake the infusion pump warnings that appear on remote controller 200 andinfusion pump 300 as similar as possible.

In one embodiment, the User Interfaces are identical for both theinfusion pump 300 and remote controller 200. Applicants have recognizedthat this feature results in a user interface that is more intuitive andless confusing for the diabetes user who may be suffering from theeffects of diabetes on their visions. In particular, warning screen1730, warning screen 1734, warning screen 1738, warning screen 1742,warning screen 1746, and warning screen 1750 are displayed on remotecontroller 200, while infusion pump warning screen 1732, infusion pumpwarning screen 1736, infusion pump warning screen 1740, infusion pumpwarning screen 1744, infusion pump warning screen 1748, and infusionpump warning screen 1752 are displayed on infusion pump 300. Warningscreen 1730 and infusion pump warning screen 1732 are displayed when abasal program edit has not been saved on infusion pump 300. As a result,basal delivery by infusion pump 300 stops. Warning screen 1734 andinfusion pump warning screen 1736 are displayed when delivery byinfusion pump 300 has been suspended. Warning screen 1738 and infusionpump warning screen 1740 are displayed when the battery in infusion pump300 is very low, and only has about another hour of use. Warning screen1742 and infusion pump warning screen 1744 are displayed when a newbolus command exceeds the maximum bolus limits set in infusion pump 300.In this case, the new bolus command is stopped. Warning screen 1746 andinfusion pump warning screen 1748 are displayed when a new bolus commandexceeds the 2-hour delivery limit that is saved in infusion pump 300. Inthis case, the new bolus command is stopped. Warning screen 1750 andinfusion pump warning screen 1752 are displayed when a new bolus commandexceeds the maximum total daily delivery limit that is saved in infusionpump 300. In this case, the new bolus command is stopped.

Although the remote controller 200 has been described in relation to ahandheld unit sized for a user's hands, the remote controller 200, in analternative embodiment, can be integrated with or implemented as part ofother remote wireless device, such as, for example, a mobile phone, PDA,pager, as long as such device includes an alphanumeric display andsufficient processing power to conduct the pairing process along withthe aforementioned pump controlling functions. It is believed thatimplementation of the mobile phone network in conjunction with the shortrange wireless network between the infusion pump and the remotecontroller allows for monitoring of therapy compliance, performance, andreal-time intervention in the event that the user is undergoing aglycemic event or other issues with the pump.

It must be recognized that equivalent structures may be substituted forthe structures illustrated and described herein and that the describedembodiment of the invention is not the only structure that may beemployed to implement the claimed invention. In addition, it should beunderstood that every structure described above has a function and suchstructure can be referred to as a means for performing that function.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. Various alternatives tothe embodiments of the invention described herein may be employed inpracticing the invention. It is intended that the following claimsdefine the scope of the invention and that methods and structures withinthe scope of these claims and their equivalents be covered thereby.

1.-9. (canceled)
 10. A method of operating a diabetes management systemhaving an infusion pump and at least a remote controller, the methodcomprising: exchanging identification information of the remotecontroller to the infusion pump and identification information of theinfusion pump to the remote controller; and permitting control of theinfusion pump by the remote controller upon (a) acceptance of the remotecontroller's identification information in the infusion pump and (b)acceptance of the infusion pump's identification information in theremote controller.
 11. The method of claim 10, in which the permittingcomprises displaying a blank screen on a display of the infusion pumpsubsequent to the permitting step.
 12. The method of claim 10, in whichthe permitting comprises transmitting the insulin sensitivity factor andtarget blood glucose range to the remote controller.
 13. The method ofclaim 12, in which the permitting comprises calculating a recommendationfor a bolus of insulin to be infused into a user by the infusion pump asa function of at least one of the blood glucose value, target bloodglucose range, carbohydrate intake by the user, quantity of insulindelivered but not absorbed, insulin sensitivity factor, and the insulinto carbohydrate ratio at the instant of bolus recommendation.
 14. Themethod of claim 13, in which the permitting comprises calculating arecommended bolus of insulin to be infused into a user by the infusionpump as a function of at least one of blood glucose value, target bloodglucose range, quantity of insulin delivered but not absorbed, andinsulin sensitivity factor.
 15. The method of claim 14, in which thecalculating comprises: determining whether a blood glucose measurementwas taken within a predetermined time period prior to the calculating;and prompting a user of the remote controller to obtain a blood glucosemeasurement in the event that a blood glucose measurement was not takenin the predetermined time frame.
 16. The method of claim 14, in whichthe calculating comprises: determining whether a blood glucosemeasurement was taken within a predetermined time period prior to thecalculating; and utilizing a blood glucose measurement taken during thepredetermined time period in the calculating of the recommended bolus.17. The method of claim 10, further comprising logging events in theinfusion pump and storing events being logged as initiated by the remotecontroller separate from events being logged as initiated by theinfusion pump.
 18. The method according to claim 17, in which the eventslogged include any actions initiated by the remote controller relatingto one of bolus delivery, bolus cancellation, bolus or basal deliverychange, suspension of infusion pump, resumption of the infusion pump,time change, alarm, or warning.
 19. The method of claim 10, in which theexchanging comprises storing only one identification information of onlyone remote controller in the infusion pump at a given time, and only oneidentification information of only one infusion pump in the remotecontroller at a given time.
 20. The method of claim 10, in which theexchanging comprises storing more than one identification information ofmore than one remote controller in the infusion pump.
 21. The method ofclaim 20, further comprising permitting control of the infusion pump bya specified one of a plurality of remote controllers upon acceptance ofa specified remote controller's identification information in theinfusion pump and acceptance of the infusion pump's identificationinformation in the specified remote controller.
 22. The method of claim10, further comprising displaying the remote controller's identificationinformation on a display of the infusion pump and displaying theinfusion pump's identification information on a display of the remotecontroller when the controller is controlling the infusion pump via awireless link.
 23. The method of claim 10, further comprising: utilizinga first plurality of user interfaces on the infusion pump; displaying ona display screen of the infusion pump a first plurality of user indicia;utilizing a second plurality of user interfaces essentially identical tothe first plurality of user interfaces; and displaying on a displayscreen of the remote controller a second plurality of user indiciaessentially identical to the first plurality of user indicia.
 24. Themethod of claim 23, in which the displaying on the screen of the remotecontroller comprises: displaying information specific only to the remotecontroller; and displaying information specific only to the infusionpump.
 25. The method of claim 10, in which the infusion pump comprisesan external insulin infusion pump carried on the body of a user.
 26. Themethod of claim 10, in which the exchanging comprises providing a userselected indicia.
 27. The method of claim 26, in which the user-selectedindicia is selected from a group consisting of a user selected textnomenclature, user selected icon, user selected audio, user selectedvisual indicia, and combinations thereof.
 28. The method of claim 10,further comprising: displaying graphical instructions on a displayscreen of at least one of the remote controller and the infusion pump.29. The method of claim 28, in which the graphical instructions comprisea series of graphical images on how to conduct at least one of a bloodglucose reading and a calibration procedure.
 30. The method of claim 10,further comprising: generating vocal instructions from a speaker of atleast one of the remote controller and the infusion pump.
 31. The methodof claim 30, in which the vocal instructions comprise a series of voiceprompts on how to conduct at least one of a blood glucose reading and acalibration procedure.